Osmoprotective Containing Lubricants in Dysfunctional Tear Syndrome and Post Refractive Surgery Patients
Study Details
Study Description
Brief Summary
The purpose of this project is to determine the effectiveness of an eyewash osmoprotective lubricant comparing to castor oil containing and non-osmoprotective lubricants in different types of DTS and post refractive surgery patients.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: optive® eye drop
|
Other: Fresh Tears ®
instilation of eye drop 4 times a day (qid)
|
Placebo Comparator: fresh tears ® eye drop
|
Other: Optive ®
instilation of 1 drop each eye 4 times per day
|
Outcome Measures
Primary Outcome Measures
- patients satisfaction with osmoprotective lubricant on different types DTS. [3 months]
Secondary Outcome Measures
- Our purpose is to determine the differential effects of Optive® castor oil Endura ® on different types DTS. [3 months]
- Physician satisfaction with Optive® [3 months]
Other Outcome Measures
- Our purpose is to determine the differential effects of Optive® vs. FreshTears ® on post refractive surgery patients. [3 monthas]
- change from baseline in Ocular Surface Disease Index (OSDI) [3 moths]
- change from baseline in tear break up time (BUT) [3 mothas]
- change from baseline in lissamine green staining [3 months]
- change form baseline in impression cytology [3 months]
- change from baseline in tear osmolarity [3 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult patients willing and able to comply with the protocol who are not planning changes in diet, topical or systemic drugs during the course of study.
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DTS all the patients will be diagnosed for mild to moderate evaporative dry eye as defined by following criteria that will be given by Outcome measurements:
2.1. Break up time. 2.2. Lissamine green staining. 2.3. OSDI and Patient Symptomatology Questionnaire.
- The patients, whose are going to be submitted for refractive surgery.
Exclusion Criteria:
-
Any patient with punctual occlusion or punctual plugs.
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Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, history of retinal detachment, concurrent contact lens use during trial period,
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Patients with glaucoma, anterior membrane dystrophy, active trichiasis or any eyelid globe malposition abnormality.
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Patients with Epiphora.
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Patients must not have participated in any investigational therapeutic drug or device trial within the 30 days prior to their start date for this trial.
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Any patient suffering from organic brain syndromes or major psychiatric disorder that would interfere with compliance or subjective reporting will be discouraged from participating in this trial.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Department of Ophthalmology, UNIFESP&EPM | Sao Paulo | SP | Brazil |
Sponsors and Collaborators
- Federal University of São Paulo
Investigators
- Principal Investigator: Rossen M Hazarbassanov, MD, Department of Ophtahlmology, UNIFESP& EPM, Sao Paulo, SP, Brazil
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1346/08